A Single-center Phase I Clinical Study Evaluating the Pharmacokinetics and Safety of Single and Multiple Oral Administration of Narfurine Hydrochloride Orally Disintegrating Tablets in Chinese Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- t1/2
研究概览
简要总结
Main objective: To evaluate the pharmacokinetics of single and multiple oral administration of narfurine hydrochloride orally disintegrating tablets in Chinese healthy adult subjects.
Secondary objective: To evaluate the safety profile of single and multiple oral administration of narfurine hydrochloride orally disintegrating tablets in Chinese healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old <= age <= 40 years old, male or female;
- •Weight: male >= 50 kg, female >= 45 kg; body mass index (BMI) in the range of 19-26 kg / m2 (including 19 and 26);
- •Important indicators including physical examination, vital signs examination, electrocardiogram examination, laboratory examination, and chest X-ray examination are normal or within the acceptable range of the sponsors or researchers;
- •During the trial and within 3 months after the last medication, there is no parenting plan and reliable contraceptive measures could be taken;
- •Fully understand the purpose and requirements of this trial, voluntarily participate in clinical trials and sign a written informed consent form, and can complete the entire trial process according to the trial requirements.
排除标准
- •Those who are known to have a history of allergies, allergic diseases or allergies to the test preparation and any of its components or related preparations;
- •Those who have a clear medical history of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders or serious infections and serious injuries, or other diseases that are not suitable for participating in clinical trials (such as history of mental illness, etc.)
- •Those who have donated blood or lost blood >= 400mL within 3 months before enrollment;
- •Those who have taken any drugs (including prescription drugs and over-the-counter drugs), vitamins, and Chinese herbal medicines within 2 weeks before screening;
- •Those who have participated in clinical trials of other drugs or medical devices within 3 months before being selected;
- •Those who is or was a drug addict or positive in drug abuse screening test;
- •Those who is or was an alcoholic (drinking more than 14 standard units per week. 1 standard unit contains 14g alcohol, such as 360mL beer or 45mL spirits with 40% alcohol or 150mL wine), or positive in urine alcohol test.
- •Smokers or those with an average daily smoking volume of more than 5 cigarettes within 3 months before screening, and those with a positive nicotine test;
- •Those who is positive in Hepatitis B surface antigen (HBsAg), HCV antibody, Treponema pallidum antibody and HIV antibody;
- •Female subjects who are in the lactation period or is positive in the pregnancy test during the screening period or clinical trial;
- •Those who have used any drugs that is CYP3A4 inhibitor or inducer within 4 weeks before signing the informed consent form, see Appendix 3 for details;
- •People with long-term insomnia and those with the habit of taking sleeping pills;
- •People with habitual constipation;
- •Those who is diagnosed abnormal or with clinical significance in physical examination, vital signs examination, electrocardiogram or clinical laboratory examination, etc.,
- •Those who have undergone surgery that can affect the absorption, distribution, metabolism, excretion of drugs, or have any gastrointestinal diseases that may affect the absorption of drugs, or those who are determined by the investigator to be unsuitable for enrollment;
- •Those who consume excessive amounts of tea, coffee and / or caffeinated beverages (more than 8 cups, 1 cup = 250mL) every day within 30 days before screening
- •Those who took grapefruit or grapefruit juice and drinks or foods containing St. John's wort (hypericum perforatum), ginseng, ginkgo, valerian, and echinacea within 48 hours before administration;
- •Those who is diagnosed abnormal or have clinical significance by researchers in the chest X-ray examination;
- •Those who develop new diseases during the pre-study screening stage or before study medication;
- •Those who cannot tolerate venipuncture blood collection;
- •Those who are thought to be unsuitable for participating in the trial by the researchers because of other factors.
研究组 & 干预措施
Pharmacokinetics study of single and multiple administration
During the study session, 30 healthy subjects will be administered a single and multiple dose of narfurine hydrochloride orally disintegrating tablets 5 µg (2.5 µg/table) to evaluate the pharmacokinetic parameters and the safety profile.
干预措施: narfurine hydrochloride orally disintegrating tablets (Drug)
结局指标
主要结局
t1/2
时间窗: Day1 to Day13
Elimination half-life
AUC AUC
时间窗: Day1 to Day13
Area Under the Plasma Concentration-time Curve
Tmax
时间窗: Day1 to Day13
Time to Reach the Maximum Plasma Concentration
Kel
时间窗: Day1 to Day13
Elimination rate constant
CL/F CL/F
时间窗: Day1 to Day13
Apparent clearance
Vd/F
时间窗: Day1 to Day13
Apparent distribution volume based on terminal elimination phase
MRT
时间窗: Day1 to Day13
Mean residence time
Css_max
时间窗: Day1 to Day13
Steady state peak concentration
Css_min
时间窗: Day1 to Day13
Steady state Valley concentration
Css_av
时间窗: Day1 to Day13
Steady state average concentration
DF
时间窗: Day1 to Day13
Volatility index
Safety and tolerance indicators
时间窗: Day1 to Day13
AE and SAE
Cmax
时间窗: Day1 to Day13
Maximum Observed Plasma Concentration
次要结局
未报告次要终点